10 
approach was more appropriate. Dr. Littlefield suggested that the report 
"Splicing Life" could be used as a resource. Dr. Walters agreed noting that 
the recommendation made to RAC at its September 19, 1983, meeting by the Working 
Group for Development of Response to President's Commission's Report on Ethical 
and Social Issues was "to consider social and ethical issues related to the 
application of recombinant DNA technologies. For specific cases... RAC should 
consider explicitly issues such as those raised in the 'Splicing Life' report 
of the President's Commission for the Study of Ethical Problems in Medicine 
and Biomedical and Behavioral Research." 
Dr. Nightingale said the report "Summing Up" by the President's Commission for 
the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research 
might also be a resource. "Summing Up" describes three ethical principles 
which should predominate in medicine and medical science. These are: (1) that 
the well-being of people be promoted; (2) that people's value preferences and 
choices be respected; and (3) that people be treated equitably. Dr. Nightingale 
requested that the portion of "Summing Up" describing these principles be 
attached to the minutes (Attachment II). 
Dr. Walters asked how the RAC review process for these proposals would be 
triggered. Dr. Gottesman said proposed Section III-A-4 would require 
these proposals be submitted to the NIH for review following IRB approval. 
Dr. Gottesman asked whether the working group could request that FEA notify 
RAC of applications received by FEA. Dr. Walters suggested that the proposed 
working group have liaison members from OPRR and FDA. The Working Group on 
Social and Ethical Issues supported this suggestion. 
Mr. Mitchell summarized the conclusions developed by the Working Gtoup on Social 
and Ethical Issues. He noted that the working group had: (1) developed language 
to modify the Guidelines; (2) developed the concept of a working group to 
evaluate proposals prior to full RAC review; (3) suggested an optimal composi- 
tion for such a working group; (4) offered some guidance on source materials 
such as "Splicing Life" and "Summing Up;" and (5) suggested mechanisms and pro- 
cedures for interaction between OPRR, IRBs, FDA, and the NIH system. He then 
adjourned the meeting at 3:15 p.m. 
Respectively submitted 
Eli^tbeth Milewski, 
Rapporteur and 
Executive Secretary 
[ 226 ] 
